US FDA Drug Development Tool Qualification Takes Center Stage At December Meeting
Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.
You may also be interested in...
FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle.
Regulators pledge to explore the use of real-world evidence, strengthen the patient's voice in drug review, and boost the agency's postmarketing surveillance abilities as part of sixth round of user fee program with industry.
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.